RecruitingPhase 1Phase 2NCT06824519

Clinical Trials of Quadrivalent Influenza Vaccine

A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Enrollment

620 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Influenza, Human

Summary

This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, a biological treatment called Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose), and others for people with influenza, human. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALInfluenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)

Inject 1 dose of low-dose vaccine

BIOLOGICALInfluenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)

Inject 1 dose of low-dose placebo

BIOLOGICALInfluenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)

Inject 1 dose of high-dose vaccine

BIOLOGICALInfluenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)

Inject 1 dose of high-dose placebo

BIOLOGICALInfluenza Vaccine (Split Virion), Inactivated, Quadrivalent

Inject 1 dose of positive control vaccine

Locations(1)

Hebei Province Centers for Disease Control and Prevention

Shijiazhuang, Hebei, China

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NCT06824519

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